HTML Preview Process Validation page number 1.
TEM-295
Issue date
Process Validation Interim / Final Report
(Reference: SOP _____)
Page 1 of 21
[Enter Product Title, Number & Strength]
PRODUCT CODE:
WRITTEN BY: REVIEWED BY:
Name:
Signature:
Position:
Date:
Qualification Status
Qualification of [enter raw material item description, item code] as per protocol [enter protocol
no]
has been completed for the following:
• [enter product name, code and lot no]
All deviations and additional protocol results for the batch are documented in this interim
report. All acceptance criteria have been met according to protocol
[enter protocol no] and all
deviations resolved.
The qualification for the use of
[enter raw material item description, item code] in the
manufacture of
enter product name, code and lot no] has been successfully completed.
• The qualification status of the use of enter raw material item description, item code] in
the manufacture of [enter product name, code and lot no] remains on-going until all
qualification data has been compiled for this study and will be documented in a subsequent
report.
REPORT COMPLETION APPROVAL:
Name:
[Type Name]
[Type Name] [Type Name]
Signature:
Position: Validation Manager Production Officer QA Team-Leader
Date:
1. OBJECTIVE
The objective of this interim report is to document the process results and process
parameters obtained during the manufacture of
[enter blend/granulate name and batch
number]
and [enter Cap/Tab product name and batch number] in the Manufacturing facility at
[enter site name].
The
[enter blend/granulate name and batch number] is the [first/second/third] validation blend
in this study manufactured for the Local market. The
[enter Cap/Tab product name and batch
number]
is the [first/second/third] run of three validation batches to be manufactured for the
[Local /export] markets. Refer to table 1.0 below for details on all the validation runs covered
in this report and from previous interim reports. A statistical review of these processes is